Safety Drug Delivery Connectors

ABSTRACT

Drug delivery connectors are provided for permitting and blocking fluid flow between a container and a catheter connector or other drug delivery site. Embodiments of the drug delivery connectors include a ball valve for forming a releasable seal within the drug delivery connectors. In one or more embodiments, the ball valve prevents fluid flow between an open proximal end and an open distal end of the drug delivery connector and is movable in a proximal direction to release the releasable seal to permit fluid flow from the open proximal direction to the open distal direction. Methods of delivering medication to a catheter connector that includes an actuator are also provided

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of pending U.S. application Ser. No. 12/711,641,filed Feb. 24, 2010, the contents of which is incorporated herein byreference.

TECHNICAL FIELD

Aspects of the present invention relate to drug delivery connectors thatprevent administration of medication to incorrect delivery ports andmethods of using the drug delivery connectors.

BACKGROUND

Drug delivery devices typically share a common ISO standard luerconnection, including intravascular, anesthesia and enteral deliverydevices. Misconnections of these routes are possible and will causemedication error. The consequences of such errors may be adverse or evenfatal.

Previous attempts at reducing errors in drug delivery include the use oflabels or color coded devices to differentiate specific route-accessingdevices (e.g., catheter connectors) and drug-containing devices orcontainers for retaining medication (e.g., syringe barrels). Studieshave shown that clinicians tend to ignore these labels and color codes.Other attempts to reduce error have required the use of valves withcontainers to prevent accidental connection and delivery. The operationof such valves often requires additional components to open the valveand/or secure attachment of the valve to the container that can becumbersome for attachment and use. The use of some of these additionalcomponents to open the valve and/or secure attachment of the valve tothe container, such a syringe barrels, has also required the use ofspecialized syringe and/or catheter connections. In specific instances,the valves may have complex structures that are difficult to manufactureand utilize and/or may utilize large surface areas on which meniscus mayform between the valve and the wall of the surrounding container withinwhich the drug is stored. Further, the large surface area of the valvesprovides an increased opportunity for microbial growth, which may causeinfection. In addition, typical valves are opened in the direction ofthe fluid flow and/or are opened by the containers that retainmedication to be dispensed. For example, conventional valves may beopened by attaching a push rod to a syringe barrel filled withmediation. The push rod activates the check valve in the direction ofthe fluid flow (from the syringe barrel or other fluid or liquidcontainer). In these configurations the syringe barrel cannot beattached to a standard hypodermic needle, which makes is impossible topre-attach the push rod connector to the syringe. Further, such valvesare generally intended to prevent fluid flow back and could contaminatethe medication source.

All of these issues could lead to the malfunction of the valve and drugdelivery procedure. In addition, the known devices do not allow the userto remove air from the container. Accordingly, there is a need for adrug delivery connector that can effectively eliminate all wrong-routemedication error possibilities for use in a variety of drug deliveryprocedures with standard syringes and other drug-containing devices.Further, there is a need for a drug delivery connector that permitsnormal aspiration of medication into a container and air priming, whileproviding a valve that prevents leakage of the aspirated medication.

SUMMARY

In this disclosure, a convention is followed wherein the distal end ofthe device is the end closest to a patient and the proximal end of thedevice is the end away from the patient and closest to a practitioner.

A first aspect of the present invention pertains to a drug deliveryconnector including a ball valve. In one or more embodiments, the drugdelivery connector comprises a housing including an open distal end, anopen proximal end and defining a chamber in fluid communication with theopen distal end and the open proximal end. The housing may also includea proximal connection portion for attaching the housing to a containerand a distal connection portion. The distal connection portion and/orthe proximal connection portion may include a luer lock fitting or aluer slip fitting. The ball valve is disposed within the chamber andforms a releasable seal with the open distal end of the drug deliveryconnector to prevent fluid flow from the open proximal end of thehousing to the open distal end of the housing.

The housing also includes a structure for forming one or more fluid flowpaths around the ball valve. The structure may be a longitudinalprotrusion, a rib, an expanding sidewall and/or combinations thereof.The chamber of the housing may also include a retaining ring thatinhibits movement of the ball valve within the chamber in the proximaldirection.

The housing of one or more embodiments may also include a proximal walldisposed adjacent to the open proximal end of the drug deliveryconnector. The proximal wall includes at least one aperture allowingconstant fluid communication between the open proximal end and thechamber of the housing. The housing may also include a distal walldisposed adjacent to the open distal end of the drug delivery connectorthat includes a bore having a perimeter that is configured to contactthe ball valve to form a releasable seal between the ball valve and thedistal wall.

In one or more embodiments, the ball valve is moveable in a proximaldirection to release the releasable seal formed with the distal wall andto permit fluid flow from the open proximal end to the open distal endupon application of a force in the proximal direction on the ball valve.In a specific embodiment, the ball valve is moveable in a distaldirection to form the releasable seal with the distal wall uponapplication of a force in the distal direction on the ball valve. Inaccordance with one or more embodiments, the attachment of a containerincluding a fluid to the proximal connection portion of the housingcauses the fluid held within the container to apply the force to theball valve in the distal direction to move the ball valve in the distaldirection. The force applied to the ball valve causes the ball valve toform a releasable seal with the open distal end.

In one or more embodiments, the drug delivery connector may include anactuator attachable or for attachment to the open distal end of thehousing. The actuator includes an open distal end and a projectionextending in the proximal direction from the open distal end. In one ormore embodiments, the projection includes at least one open path oraperture in fluid communication with the open distal end of the actuatorand the open distal end of the housing. Upon attachment of the actuatorto the open distal end of the housing, the projection extends throughthe bore of the distal wall into the chamber and applies a force on theball valve in the proximal direction to move the ball valve in theproximal direction. In one or more embodiments, the ball valve ismovable in the proximal direction upon application of a minimum orpre-determined force on the ball valve in the proximal direction. In oneor more embodiments, a coil spring or other device may be disposedwithin the housing to exert a constant force on the ball valve in thedistal direction. The spring constant of the coil spring may be adjustedor selected to select the minimum or pre-determined force required torelease the seal between the ball valve and the distal wall.

In accordance with a second aspect of the present invention, the drugdelivery connector includes a housing including an open distal end, anopen proximal end and a chamber in fluid communication with the opendistal end and the open proximal end, means for attaching the housing toa catheter connector comprising an actuator, means for attaching thehousing to a container and means for permitting and blocking fluidcommunication between the container and the catheter connector from theopen proximal end to the open distal end. In one or more embodiments,the means for permitting and blocking fluid communication comprises aball valve. In a specific embodiment, the means for permitting andblocking fluid communication comprises a spring-loaded ball valve.

A third aspect of the present invention pertains to a method ofdelivering liquid medication to a catheter connector. In one or moreembodiments, the method includes attaching an actuator, as describedherein, to a catheter, providing a drug delivery connector a housingwith an open distal end, an open proximal end and a chamber with avalve, as described herein, in fluid communication with the open distalend and open proximal end of the housing, attaching a tip of a syringebarrel to the open proximal end of a drug delivery connector, fillingthe syringe barrel with a pre-determined amount of liquid medication,filling the chamber of the drug delivery connector with the liquidmedication to form a seal between the valve and the open distal end andreleasing the seal between the valve and the open distal end byattaching the open distal end to the actuator. In one or moreembodiments, the actuator includes a projection with a length thatextends into the chamber of the housing. The projection may include anaperture or open path in fluid communication with the catheterconnector. The step of releasing the seal between the valve and the opendistal end may include causing the projection of the actuator to apply aforce to the valve in a proximal direction. In one or more embodiments,the step of releasing the seal between the valve and the open distal endpermits the liquid medication to flow from the chamber to the open pathof the projection.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a disassembled perspective view of one or moreembodiments of the drug delivery connector shown with a syringe barreland a actuator;

FIG. 2 illustrates an perspective view of the drug delivery connectorshown in FIG. 1 assembled with the actuator;

FIG. 3 illustrates an enlarged view of the drug delivery connector andactuator shown in FIG. 1;

FIG. 4 illustrates a perspective cross-sectional view of the drugdelivery connector and actuator shown in FIG. 3 taken along line 4-4from the view point of the distal end of the drug delivery connector andactuator;

FIG. 5 shows a perspective cross-sectional view of the drug deliveryconnector shown in FIG. 4;

FIG. 6 illustrates side-elevational view of a drug delivery connectorshown in FIG. 5;

FIG. 7 shows a perspective cross-sectional view of the drug deliveryconnector shown in FIG. 4 including a distal wall according to one ormore embodiments of the present invention, a ball valve and a coilspring;

FIG. 8 shows a view of the drug delivery connector shown in FIG. 7including a distal wall and sidewall according to one or moreembodiments of the present invention and a ball valve;

FIG. 9 shows a view of the drug delivery connector shown in FIG. 7including a distal wall and sidewall according to one or moreembodiments of the present invention and a ball valve;

FIG. 10 shows a view of the drug delivery connector shown in FIG. 7including a distal wall and sidewall according to one or moreembodiments of the present invention and a ball valve;

FIG. 11 shows a view of the drug delivery connector shown in FIG. 7including a distal wall and sidewall according to one or moreembodiments of the present invention and a ball valve;

FIG. 12 shows a view of the drug delivery connector shown in FIG. 7including a distal wall and sidewall according to one or moreembodiments of the present invention and a ball valve;

FIG. 13 illustrates a cross-sectional view of the proximal end of thedrug delivery connector shown in FIG. 4 taken along line 13-13 includinga proximal wall according to one or more embodiments of the presentinvention;

FIG. 13A shows a perspective view of the drug delivery connector shownin FIG. 13;

FIG. 14 shows the proximal end of the drug delivery connector shown inFIG. 13 including a proximal wall according to one or more embodimentsof the present invention;

FIG. 14A shows a perspective view of the drug delivery connector shownin FIG. 14;

FIG. 15 shows the proximal end of the drug delivery connector shown inFIG. 13 including a proximal wall according to one or more embodimentsof the present invention;

FIG. 15A shows a perspective view of the drug delivery connector shownin FIG. 15;

FIG. 16 shows a perspective cross-sectional view of a drug deliveryconnector according to one or more embodiments;

FIG. 17 illustrates a cross-sectional view of a drug delivery connectorattached to a syringe barrel and a needle hub positioned with a vial todraw liquid into the syringe barrel;

FIG. 18 shows the drug delivery connector, syringe barrel and needle hubshown in FIG. 17 as liquid is being aspirated from the vial into thesyringe barrel;

FIG. 19 illustrates a cross-sectional view of the drug deliveryconnector and syringe barrel shown in FIG. 18 filed with liquid;

FIG. 20 shows a cross-sectional view of the drug delivery connectorshown in FIG. 5 assembled with a syringe and an unassembled actuatoraccording to one or more embodiments;

FIG. 21 shows an enlarged partial view of the drug delivery connector,syringe and actuator shown in FIG. 20;

FIG. 22 illustrates the drug delivery connector and syringe and actuatorof FIG. 20 in an assembled state; and

FIG. 23 illustrates an enlarged partial view of the drug deliveryconnector, syringe and actuator shown in FIG. 22.

DETAILED DESCRIPTION

Before describing several exemplary embodiments of the invention, it isto be understood that the invention is not limited to the details ofconstruction or process steps set forth in the following description.The invention is capable of other embodiments and of being practiced orbeing carried out in various ways.

Aspects of the present invention pertain to drug delivery connectors.The drug delivery connectors may be utilized for delivery of medicationfrom a container to delivery site for delivery to a patientintravenously or via epidural space. Exemplary containers includesyringe barrels, IV bag or other medical devices used to store,transport and/or delivery anesthesia. In one or more embodiments, thedrug delivery connector provides a fluid-tight connection mechanismbetween a delivery site and a container. In a specific embodiment, thedrug delivery connector provides a fluid-tight connection mechanismbetween a catheter connector or other delivery site and a syringebarrel. The fluid-tight connection mechanism between a delivery site anda drug container may include a filter. Examples of connection mechanismsutilized to connect a delivery site and syringe barrel to the drugdelivery connectors described herein include standard luer slipconnections or standard luer lock connections. The drug deliveryconnectors described herein include a structure to prevent flow ofmedication from the container when attached to an inappropriate deliverysite and permit flow of medication from the container when attached toan appropriate delivery site.

In accordance with one or more embodiments, the drug delivery connectorincludes a ball valve disposed in the flow path of the medication from acontainer to a delivery site. The ball valve of one or more embodimentsforms a one-way valve or a check valve. As used herein, the term“one-way valve” includes any valves which permit fluid flow in onedirection. As used herein, the terms “check valve” may be usedinterchangeably with the term “one-way valve.” In a specific embodiment,the ball valve is activated or opened by an actuator, which may be inthe form of a push rod and may not be activated or opened by thecontainer or even the delivery site. In a more specific embodiment, theball valve is activated by the actuator, which may include a catheterconnector for connection of the drug delivery connector and container toa catheter or other delivery site. The ball valve prevents fluid flowacross the drug delivery connector from the container to the actuatorand, thus, the delivery site. The ball valve permits the user to attachthe drug delivery connector to at least one of the container and/oractuator without accidental expulsion of medication from the container.Further the drug delivery connector may be used with containers withoutfear of leakage or accidental administration of the medication containedtherein.

A drug delivery connector 100 according to a first aspect is shown inFIGS. 1-6. As shown more clearly in FIGS. 4-6, the drug deliverconnector 100 includes an open distal end 101 and an open proximal end109. The drug delivery connector includes a housing 110, a distalconnection portion 150 extending from the housing 110 to the open distalend 101 of the drug delivery connector and a proximal connection portion170 extending from the housing 110 to the open proximal end 109 of thedrug delivery connector. The distal connection portion 150 is in fluidcommunication with the housing 110 and the proximal connection portion170.

For illustration in FIGS. 1-6, a container in the form of a syringebarrel 300 is utilized with the drug delivery connector 100, althoughthe drug delivery connector according to one or more embodiments mayalso be utilized with other types of containers, for example, an IV bag.In addition, an actuator 200 including a catheter connector 210 is alsoincluded for illustration.

As more clearly shown in FIGS. 4-5, the distal connection portion 150includes a distal end 151 and a proximal end 159 including a distal luerfitting for attaching the actuator 200 to the drug delivery connector.In one or more embodiments, the distal connection portion 150 of one ormore embodiments may include a fitting in the form of a luer slipfitting (not shown) for connection to an actuator 200. In the embodimentshown in FIGS. 1-6, the distal connection portion 150 includes a fittingin the form of a luer lock fitting including an elongate tube 152 influid communication with the housing 110 and extending from the housing110 to the open distal end 101 of the drug delivery connector. Theelongate tube 152 includes an outside surface 154 and a coaxial wall 156surrounding the elongate tube 152 and defining an inside surface 158that forms a channel 160 between the inside surface 158 of the coaxialwall 156 and the elongate tube 152. In one or more embodiments, theinside surface 158 of the coaxial wall 156 includes a threaded portion162 for engaging the actuator 200. The elongate tube includes an insidesurface 153 defining a passageway 155 for receiving the actuator 200 (asshown more clearly in FIG. 4). The actuator 200 is shown in FIGS. 1-4and 20-22 is an example of one or more suitable actuators for activatingthe ball valve 190 and includes catheter connector 210 for attachment ofthe actuator 200 to a filter system, catheter or other delivery site. Inuse, the actuator 200 is inserted into the passageway 155 of the distalconnection portion 150 of the drug delivery connector. As will bedescribed in further detail below, the actuator 200 may also include acorresponding structure that allows the actuator 200 to be threaded withthe threaded portion 162 of the distal connection portion 150 of thedrug delivery connector 100. In one or more embodiments, the flow rateof the medication flowing from the container through the drug deliveryconnector 100 and to the actuator 200 may be modified or controlled bycontrolling the level of engagement between the actuator 200 and thedrug delivery connector 100. In one or more specific embodiments, theflow rate may be controlled by controlling the amount of rotationapplied to the actuator 200 with respect to the drug delivery connector100 during attachment.

As shown in the embodiment in FIGS. 4-5, the proximal connection portion170 of the drug delivery connector extends from the housing 110 towardthe open proximal end 109 of the drug delivery connector 100. Theproximal connection portion 170 includes a proximal luer fitting in theform of an elongate hollow body 172 having an open distal end 171, anopen proximal end 179 and an inside surface 173 defining an interior 175for receiving and engaging an opening of a container, for example, anopen tip 314 of the syringe barrel 300 shown in FIG. 1. In one or moreembodiments, the elongate hollow body 172 includes an outside surface176 with at least one radially outwardly extending ridge 177 disposedadjacent to the open proximal end 179. In the embodiment shown, theelongate hollow body 172 includes two ridges 177, 178 disposed onopposite ends of the proximal end of the elongate hollow body 172. Inone or more embodiments, the at least one radially extending ridge 177may extend radially along a portion of circumference of the openproximal end 179 or the entire circumference of the open proximal end179. The at least one radially outwardly extending ridge 177 permitsassembly of the drug delivery connector 100, and, more specifically, theproximal connection portion 170, to a container, for example, thesyringe barrel 300 shown in FIG. 1, which may having a luer lockattachment 310 including the open tip 314 and a threaded section 312surrounding the open tip 314, as shown in FIGS. 1 and 17-18. To assemblethe syringe barrel 300 with a luer lock attachment 310 to the proximalconnection portion 170 of the drug delivery connector 100, the open tip314 is inserted into the open proximal end 179 of the elongate hollowbody 172 and the syringe barrel 300 and/or the drug delivery connector100 is rotated relative to one another. During rotation, the threadedsection 312 of the luer lock attachment 310 engages the at least oneradially outwardly extending ridge 177. In the embodiment shown in FIG.18, the threaded section 312 engages both radially outwardly extendingridges 177, 178 of the proximal connection portion 170.

In one or more embodiments, the proximal connection portion 170 maypermit connection of the drug delivery connector 100 to a syringe with aluer slip tip (not shown). In such embodiments, the inside surface 173of the elongate hollow body 172 of the proximal connection portion 170may have a cross-sectional width that increases along the length of theelongate hollow body 172 from the open distal end 171 toward the openproximal end 179 forming a tapered portion (not shown) that frictionallyengages the luer slip tip (not shown) of a syringe barrel. To assemble asyringe barrel having a luer slip tip (not shown) to the proximalconnection portion 170 of the drug delivery connector, the luer slip tip(not shown) of the syringe barrel is inserted into the interior 175 ofthe elongate hollow body 172. A force in the distal direction is appliedto the syringe barrel relative to the drug delivery connector 100 untilthe tapered portion (not shown) of the elongate hollow body 172 and theinside surface 173 prevents further movement of the luer slip tip (notshown) in the distal direction relative to the drug delivery connector100 and the luer slip tip (not shown) is frictional engaged with theinside surface 173 of the proximal connection portion 170.

The housing 110 includes a sidewall 112 having an axial length and aninterior surface 114 defining chamber 116. In one or more embodiments,the chamber 116 is cylindrically shaped and has a distal end 111 influid communication with the open distal end 151 of the distalconnection portion 150 and a proximal end 119 in fluid communicationwith the open proximal end 179 of the proximal connection portion 170.In one or more embodiments, the distal end 111 includes a distal wall130 disposed between the chamber 116 and the distal connection portion150. The distal wall 130 includes at least one bore 132 therethroughhaving a perimeter 134 to permit fluid communication between the distalconnection portion 150 and the chamber 116. The proximal end 119includes a proximal wall 140 disposed between the chamber 116 and theproximal connection portion 170. The proximal wall 140 includes at leastone aperture 142 to allow fluid communication between the proximalconnection portion 170 and the chamber 116. As will be described in moredetail below, the proximal wall 140 has a structure to prevent theformation of a seal that closes the aperture 142 or, in other words,structure that maintains fluid communication between a container and thechamber 116 when the container is attached to the drug deliveryconnector 100.

In the embodiment shown in FIGS. 1-6, the chamber 116 of the housing 110includes a ball valve 190. As will be described below in more detail,the ball valve 190 cooperates with an actuator 200 to permit fluidcommunication between the syringe barrel 300, drug delivery connector100 and a delivery site which may include a catheter (not shown) and/orfilter (not shown). The ball valve 190 cooperates with the distal wall130 to prevent fluid communication between the chamber 116 and thedistal connection portion 150 through bore 132. According to one or moreembodiments, the ball valve 190 remains closed and prevents fluidcommunication between the chamber 116 and the distal connection portion150 when the drug delivery connector 100 is attached to a syringe barrel300 that is filled with medication because the pressure from themedication contained within the syringe barrel 300 applies a continuousforce on the ball valve 190 in the distal direction to close the ballvalve 190 against the distal wall 130.

In one or more embodiments, the ball valve 190 is sized to fit withinthe chamber 116 of the housing 110 and has a solid spherical shape andcircular cross-section having a dimension and shape to form a releasableseal with the distal wall 130, thereby closing the bore 132 andpreventing fluid communication between the chamber 116 and the distalconnection portion 150. The ball valve 190 may be formed from a rubber,plastic, metal or ceramic material or combinations thereof. In one ormore specific embodiments, the ball valve 190 may be formed from asynthetic rubber and/or a polyurethane material. In a specificembodiment, the ball valve 190 may be formed from a commonly usedplastic or other material and coated with synthetic rubber or otherpolyurethane-containing materials. The ball valve 190 “floats” or ismoveable within the chamber in the proximal and distal direction. Forcessuch as gravity may cause the ball valve 190 to move in either theproximal or distal direction. Other forces such as fluid pressure maycause the ball valve 190 to close the bore 132 or to move in the distaldirection to form a seal with the perimeter 134 of the distal wall 130.

Embodiments of the present invention utilize ball valves 190 with areduced surface area than other valves known and used in the art. Areduced surface area eliminates the issues regarding movement of theball valve within the chamber 116 and reduces the possibility ofmeniscus forming between the ball valve 190 and the chamber 116, whichcould further inhibit movement of the ball valve 190. The reducedsurface area of the ball valve 190 also reduces the possibility ofmicrobials forming on the surface of the ball valve 190, which can beespecially problematic when the drug delivery connector 100 is used withimplanted medical devices, such as catheters, which may remain implantedfor several days at a time. In addition, the spherical shape of ballvalve 190 facilitates manipulation of the ball valve 190 and eliminatesproblems of misalignment of the ball valve 190 within the chamber 116due to varying forces exerted at different locations of the ball valve190.

In accordance with one or more embodiments, the ball valve 190 may bespring-loaded. A drug delivery connector including a coil spring 192disposed within the chamber 116 of the housing 110 is shown in FIG. 8.The coil spring 192 includes a distal end 193 disposed adjacent to theball valve 190 and a proximal end 194 disposed adjacent to the proximalwall 140. In an inactivated state, the coil spring 192 is expanded, andapplies a constant force on the ball valve 190 in the distal direction,forcing the ball valve 190 to remain in contact with the distal wall 130sealing the bore 132. Other known structures for applying a constantforce on the ball valve may also be utilized. To open the ball valve190, the user would apply a force on the ball valve 190, on the oppositeside of the coil spring 192, in the proximal direction. The proximallydirected force applied to the ball valve 190 compresses the coil spring192 and forces the ball valve 190 to move away from the distal wall 130to permit fluid communication between the chamber 116 of the housing andthe bore 132 in the distal wall 130. In one or more embodiments, thespring constant of the coil spring may be adjusted to require a minimumor pre-determined amount of force to activate or open the ball valve.

To form a seal with the bore 132 of the distal wall 130, the ball valve190 is seated adjacent to the bore 132 and in contact with the distalwall 130. In one or more embodiments, the bore 132 has a cross-sectionalwidth forming a seat that receives the ball valve 190. In one or moreembodiments, for example, as shown in FIG. 6, the distal wall 130 isvertically disposed or is disposed perpendicularly to the sidewall 112of the chamber 116 to form a distal wall 130 having a flatconfiguration. The contact between the ball valve 190 and the distalwall 130 with a flat configuration may be described as a line contact.

In a specific embodiment, the distal wall 130 may be contoured adjacentto the perimeter 134 and the bore 132 to further facilitate theformation of a seal between the distal wall 130 and the ball valve 190.In accordance with one or more embodiments, as shown in FIGS. 7 and 8,the distal wall 130 may include a chamfer 135 forming a beveled seat 136for the ball valve 190. The chamfer 135 allows for a greater surfacearea of contact between the ball valve 190 and the distal wall 130. Insuch a configuration, defects or modifications on the surface of thedistal wall 130 are not as likely to compromise the seal formed betweenthe ball valve 190 and distal wall 130 as configurations that provide asmaller surface area of contact between the ball valve and the distalwall 130.

In one or more embodiments, as shown in FIG. 9, the distal wall 130 mayextend proximally into the chamber 116 to form a sharp contact point 137forming a “sharp contact” with the ball valve 190. Sharp contact betweenthe sharp contact point 137 and the ball valve 190 is formed when thedistal wall 130 is positioned at an angle of less than 90 degreesrelative to the sidewall 112. In other words, during sharp contactbetween the ball valve 190 and the sharp contact point 137 forms asingle line of contact with the ball valve 190. The single line ofcontact decreases the likelihood of a defect on the distal wall 130and/or the ball valve 190 will interfere with the formation of a seal.The decreased contact area between the ball valve 190 and the perimeter134 increases pressure on the ball valve 190 and compresses the ballvalve 190. This compression improves the seal formed between the distalwall 130 and the ball valve 190. Compression of the ball valve 190 isparticularly pronounced when the ball valve 190 is composed of a softermaterial or material with smaller elasticity, because it permitsdispersal of the force exerted on the ball valve 190, which is not aspossible when the ball valve is composed of more rigid materials.

In one or more embodiments, the chamber 116 of the housing 110 may bemodified to align the ball valve 190 in the center of the fluid path.For example, in one or more embodiments, the interior surface 114 mayinclude one or more structures or structural features that permitmovement of the ball valve 190 in the proximal and distal directionswithin the chamber 116 but prevent lateral movement of the ball valve190. In FIG. 6, the interior surface 114 of the sidewall 112 includes atleast one longitudinal protrusion 120 extending radially outwardly intothe chamber 116 of the housing 110. The longitudinal protrusion 120defines a smaller cross-sectional width than the cross-sectional widthdefined by the interior surface 114 of the sidewall 112. The reducedcross-sectional width defined by the longitudinal protrusion 120prevents or reduces lateral movement of the ball valve 190 toward thesidewall 112, while providing a flow path for fluid to flow past theball valve 190 when the seal between the distal wall 130 and the ballvalve 190 is released.

In one or more embodiments, the cross-sectional width of the interiorsurface 114 of the chamber 116 and the cross-sectional width of the ballvalve 190 are sized to permit movement of the ball valve 190 distallyand proximally within the chamber 116 but prevent lateral movement ofthe ball valve 190 toward the sidewall 112 of the housing, which mayoccur when the flow rate of the medication is low and less pressure isbeing exerted on the ball valve 190 in the distal direction.

In one or more embodiments, a plurality of longitudinal protrusions 121is provided along the length of the housing 110, as shown in FIGS. 7-8.The plurality of longitudinal protrusions 121 reduce the cross-sectionalwidth of the chamber 116 within which the ball valve 190 may move in theproximal and distal direction but provide multiple flow paths for fluidto flow past the ball valve 190 when the seal between the perimeter 134of the distal wall 130 and the ball valve 190 is released.

The length, dimensions and/or placement of the longitudinal protrusionsor other similar structure may be modified according to the needs of aparticular application. For example, if the drug delivery connector isused with a medication that is more viscous, larger or more flow pathsmay be needed to facilitate flow between the container and the deliverysite. In another example, in one or more embodiments, as shown in FIG.10, the interior surface of chamber may include a plurality of ribs 122extending from the distal wall 130 to a proximal wall 140 to align theball valve 190 in the center of the fluid path without significantlyreducing the flow rate of the medication flowing from a containerthrough the drug delivery connector 100. As shown in FIG. 10, theplurality of ribs 122 provides additional fluid flow paths for thefluid, once the seal between the distal wall 130 and the ball valve 190is released. The plurality of ribs 122 is configured to permitrotational and non-rotational movement of the ball valve 190 in thedistal and proximal directions within the chamber. In a specificembodiment, the interior surface 114 of the chamber 116 includes two ormore ribs (not shown) permit fluid communication between the distalconnection portion 150 and the chamber 116 when the seal between theball valve 190 and distal wall 130 is released.

In a specific embodiment, as shown in FIG. 11, the cross-sectional widthof the interior surface 114 of the sidewall 112 may increase from thedistal connection portion 150 to the proximal connection portion 170. Inone or more embodiments, the cross-sectional width of the interiorsurface 114 of the sidewall 112 may increase linearly. In the embodimentshown in FIG. 10, the housing 110 includes an expanding sidewall 123including an inside surface 124 defining a cross-sectional width thatincreases substantially linearly or constantly from the distal end 111to the proximal end 119 of the housing. In the embodiment shown in FIG.11, the cross-sectional width of the sidewall 112 increases “stepwise”along the axial length of the sidewall 112. In such embodiments, thesidewall 112 has a first portion 125 extending from the distal wall 130along the axial length of the sidewall 112 for a first length and asecond portion 126 extending from the first portion 125 to the proximalwall 140. The cross-sectional width of the first portion 125 may besmaller than the cross-sectional width of the second portion 126. In oneor more embodiments, the cross-sectional width of the first portion 125may increase from the distal wall 130 to the second portion 126 orremain constant. In one or more embodiments, the cross-sectional widthof the second portion 126 may increase from the first portion 125 to theproximal wall 140 or may remain constant. In another embodiment, thecross-sectional width of the first portion 125 and the second portion126 increases at the same or different rates. As shown in FIG. 11, atransition portion 118 may be included between the first portion 125 andthe second portion 126. In the embodiment shown, the cross-sectionalwidth of the first portion 125 is smaller than the second portion 126but is constant from the distal wall 130 to the transition portion 118.The second portion 126 is shown as having a cross-sectional width largerthan the first portion 125 but is constant from the transition portion118 to the proximal wall 140 with the transition portion 118 having across-sectional width that increases from the first portion 125 to thesecond portion 126.

In one or more embodiments, the sidewall 112 of the chamber 116 mayinclude one or more structural features to align the ball valve in thecenter of the fluid path. These structural features may also exert adistally directed force on the ball valve 190 to prevent the ball valve190 from moving in the proximal direction, when the force exerted on theball valve varies, for example, during air priming or the removal of airfrom within the syringe or container and before delivery of themedication to the intended delivery site. In one or more embodiments,these structural features prevent movement of the ball valve 190 in theproximal direction and require the exertion of a greater force on theball valve 190 to move the ball valve 190 in the proximal direction. Inone or more embodiments, a structural feature that prevents movement ofthe ball valve 190 in the proximal direction is shown in FIG. 12. InFIG. 12, the sidewall 112 of the housing 110 the sidewall defines aradial length or circumference and includes a retainer ring 127extending radially inwardly into the chamber 116. The retaining ring 127may be formed along discrete portions of the radial length of thesidewall 112 or, alternatively, along the entire radial length of thesidewall 112. In one or more embodiments, the retaining ring 127includes a perpendicular wall 128 extending radially inwardly into thechamber 116 from the sidewall 112 that defines a cross-sectional widthalong the retaining ring 127 that is smaller than the cross-sectionalwidth of the sidewall 112. In one or more embodiments, the perpendicularwall 128 includes a beveled inside edge 129. In such embodiments, thebeveled inside edge 129 may define a cross-sectional width at increasesin the proximal direction along the axial length of the perpendicularwall 128. In an alternative embodiment, the beveled inside edge 129 maydefine a cross-sectional width that decreases in the proximal direction.In one or more embodiments, the beveled inside edge 129 retains the ballvalve 190 in the closed position in contact with the perimeter 134 ofthe distal wall 130 by forming a physical barrier to movement of theball valve 190 in the proximal direction. In one or more embodiments,the perpendicular wall may include a flat inside edge (not shown) thatdefines a constant cross-sectional width along the axial length of theperpendicular wall 128.

In an even more specific embodiment, the interior surface 114 of thechamber 116 and/or the retaining ring 127 may include one or more raisedportions (not shown) extending radially that also form a physicalbarrier to movement of the ball valve 190 in the proximal direction butalso provide an open flow path for medication to flow from a syringebarrel through the drug delivery connector 100 when the drug deliveryconnector 100 is attached to a actuator and the seal between the ballvalve 190 and the perimeter 134 of the distal wall 130 is released. Inone or more embodiments, the height of the raised portions (not shown)may be adjusted to exert more or less pressure on the ball valve in thedistal direction. For example, the height and/or shapes of the raisedportions may be increased to exert a greater force on the ball valve inthe distal direction and/or to form a physical barrier that is moredifficult to overcome than raised portions having a decreased height. Inone or more embodiments, the raised portions may also be beveled toexert an even greater force on the ball valve in the distal direction toprevent proximal movement thereof. The chamber of one or moreembodiments may include a combination of the longitudinal protrusion120, the plurality of longitudinal protrusions 121, expanding sidewall123, the retaining ring 127 and/or the plurality of raised portions (notshown).

The aperture 142 of the proximal wall 140 of the housing 110 providesfluid communication between with the chamber 116 and the open proximalend 179 of the proximal connection portion 170. In one or moreembodiments, the proximal wall 140 may include more than one aperture142. As shown in FIGS. 13-15, the proximal wall 140 may also include astructure to prevent the formation of a seal between the ball valve 190and the aperture 142. In other words, the proximal wall 140 includes astructure that maintains fluid communication between the chamber 116 andthe proximal connection portion 170. In one or more embodiments, theproximal wall 140 may include an irregular contour or geometry thatprevents the formation of a seal between the ball valve 190 having aregular spherical geometry.

In one or more embodiments, the proximal wall 140 may include a seriesof telescoping conduits extending in a fixed position with respect toeach other and extend from the chamber 116 to the proximal connectionportion 170. FIGS. 13-15 illustrate embodiments which utilizestelescoping conduits that surround the aperture 142 and defining aconduit space. In such embodiments, a first conduit 143 extends in theproximal direction from the side wall 112 of the housing 110 and definesa first cross-sectional width, a second conduit 144 defining a secondcross-sectional width extends from the first conduit 143 in the proximaldirection to a third conduit 145 defining a third cross-sectional widthextends from the second conduit 144 in the proximal direction. In one ormore embodiments, the telescoping conduits have varying axial lengthsextending in the proximal direction. The cross-sectional widths definedby the telescoping conduits may further decrease from the first conduit143 to the third conduit 145 further have a decreasing cross-sectionalwidth. For example, the first cross-sectional width of the first conduit143 may be larger than the second cross-sectional width of the secondconduit 144. In one or more embodiments, the second cross-sectionalwidth of the second conduit 144 may be larger than the thirdcross-sectional width of the third conduit 145.

In one or more embodiments, the first conduit 143 may include firstinside surface 146 defining a first conduit space in fluid communicationwith the aperture 142. The first inside surface includes one or moreguide bars 148 extending partially into the first conduit space. In oneor more embodiments, the one or more guide bars 148 extend along theaxial length of the first conduit 143 and are disposed at equaldistances along the first inside surface 146. In one or moreembodiments, the second conduit 144 may include a second inside surface147 defining a second conduit space and includes at least one transversebeam 149 extending across the aperture 142, intersecting the aperture142 into two openings along the axial length of the second conduit 144.In the embodiment shown in FIGS. 14 and 14A, the second conduit 144includes two transverse beams 149 extending from equally spaced pointsalong the second inside surface 147 of the second conduit 144 andintersecting at a midpoint in the aperture 142, intersecting theaperture 142 into four equally sized openings along the axial length ofthe second conduit 144. In the embodiment shown in FIGS. 15 and 15A, thesecond conduit 144 includes three transverse beams 149 extending fromequally spaced points along the second inside surface 147 toward amid-point in the aperture 142. The three transverse beams 149 shown inFIGS. 15 and 15A intersect the aperture 142 into three equally sizedopenings along the axial length of the second conduit 144. In one ormore embodiments, the transverse beam or beams 149 have an axial lengththat extends along the axial length of the second conduit 144 andoccupies the second conduit space. In a more specific embodiment, thetransverse beam or beams 149 may have an axial length that extendsbeyond the axial length of the second conduit 144 and extends into thefirst conduit space of the first conduit 143. FIGS. 13A, 14A and 15Aillustrate one or more transverse beams 149 that extend into the firstconduit space. In one or more embodiments, the third conduit 145 is freeof any additional structures and surrounds the aperture 142 adjacent tothe proximal connection portion 170.

The arrangement of the guide bars 148, the first conduit 143, secondconduit 144, third conduit 145 and/or transverse beam 149 preventformation of a seal between the ball valve 190 and the proximal wall 140because they do not provide a circular edge with which the ball valve190 may from a line contact interaction. Instead, the guide bars 148,the first conduit 143, second conduit 144, third conduit 145 and/ortransverse beam 149, alone or in combination, form an irregular edge orirregular contact points with the ball valve 190 that prevent theformation of a seal between the ball valve 190 and the proximal wall140.

In one more alternative embodiments, the proximal wall 140 may include aplurality of telescoping walls (not shown) extending proximally in afixed configuration and surrounding the aperture 142 for preventing theformation of a seal between the ball valve and the proximal wall. Theplurality of telescoping walls including a first annular wall (notshown) disposed adjacent to the sidewall of the housing, a secondannular wall (not shown) between the first annular wall and a thirdannular wall (not shown). In one or more embodiments, the third annularwall (not shown) is disposed between the second annular wall (not shown)and the aperture 142. The first annular wall (not shown), second annularwall (not shown) and/or third annular wall (not shown) may have athickness that elongates the chamber 116 and extends the chamber 116 atleast partially into the interior 175 of the proximal connection portion170. The first annular wall (not shown) may have a first thickness andthe second annular wall may have a second thickness, wherein the firstand second thicknesses may be the same or different. The third annularwall (not shown) may be integrally formed with the proximal connectionportion 170 and may define the aperture 142.

In one or more embodiments, the first annular wall (not shown) mayinclude a plurality of detents (not shown) that extend inwardly onto thesecond annular wall (not shown). The plurality of detents (not shown)are shaped and disposed to prevent formation of a seal between the ballvalve 190 and the proximal wall 140. In one or more embodiments, theplurality of detents (not shown) may be disposed on the second annularwall (not shown) and extend inwardly onto the third annular wall (notshown). The plurality of detents (not shown) may be disposed equidistantfrom the aperture 142 and each other along the perimeter of the one ormore of the first annular wall (not shown), second annular wall (notshown), and/or third annular wall (not shown). In one or more specificembodiments, four detents may be utilized and may be disposed along thefirst annular wall (not shown) so that they extend inwardly and onto thesecond annular wall (not shown).

In one or more embodiments, one or more of the first annular wall (notshown), second annular wall (not shown) and/or third annular wall (notshown) may include at least one transverse beam extending across theaperture from opposite ends of the wall. In a specific embodiment, thesecond annular wall may include a single transverse beam attached atopposite sides of the second annular wall (not shown) and extendingacross the aperture 142. The second annular wall may also include twotransverse beams (not shown) that intersect at the mid-point of theaperture 142 and divide the at least one aperture 142 into fourapertures. In a more specific embodiment, the second annular wall mayinclude three transverse beams (not shown) extending into the aperture142 and intersecting at a mid-point of the aperture 142. In suchembodiments, the three transverse beams (not shown) divide the at leastone aperture 142 into three apertures. The transverse beam (not shown)may be raised from the annular wall on which it is formed and/orconnected so it extends proximally into the chamber. In other words, thetransverse beam (not shown) may extend proximally from the first annularwall (not shown), second annular wall (not shown) and/or third annularwall (not shown) into the chamber 116 to create provide an unlevelsurface or seat for the ball valve 190 adjacent to the first, secondand/or third annular walls.

The arrangement of the detents (not shown), the first annular wall (notshown), second annular wall (not shown), third annular wall (not shown)and/or transverse beam (not shown), described herein, prevent formationof a seal between the ball valve 190 and the proximal wall 140 becausethey do not provide a circular edge with which the ball valve 190 mayfrom a line contact interaction. Instead, the detents (not shown), thefirst annular wall (not shown), second annular wall (not shown), thirdannular wall (not shown)and transverse beam (not shown)form an irregularedge or irregular contact points with the ball valve 190, which togetherand individually, prevent the formation of a seal between the ball valve190 and the proximal wall 140.

In alternative embodiments, the proximal wall 140 may utilize othermeans to prevent formation of a seal between the ball valve 190 and theat least one aperture 142. For example, the proximal wall 140 mayinclude a plurality of apertures (not shown) dispersed along theproximal wall 140. In this embodiment, the at least one aperture 142disposed along the proximal wall 140 remain open regardless of theposition of the ball valve 190. In one or more embodiments, as shown inFIG. 16, the proximal wall 140 may include one or more protuberances 141extending distally into the chamber 116 that prevent the ball valve 190from being forming a seal with the proximal wall 140.

An actuator 200 may be provided with the drug delivery connector 100either separately or pre-attached to a catheter connector 210. A syringebarrel 300 and/or a hypodermic needle 400, which may include a metal orplastic cannula that may be blunt, may also be provided separately orattached to the drug delivery connector 100. The hypodermic needle 400may be provided with a needle hub 410, as shown in FIG. 17. In one ormore embodiments, the drug delivery connector 100, syringe barrel 300and hypodermic needle 400 are provided in a kit. In a specificembodiment, the drug delivery connector 100, syringe barrel 300,hypodermic needle 400 and actuator 200 may be provided in a kit. In amore specific embodiment, the drug delivery connector 100, syringebarrel 300, hypodermic needle 400, actuator 200 and catheter connector210 may be provided in a kit. In one or more embodiments, the catheterconnector 210 may optionally include a filter. Alternatively, the drugdelivery connector 100, syringe barrel 300, actuator 200, catheterconnector 210, hypodermic needle 400 and/or filter may be providedseparately.

In one or more alternative embodiments, the drug delivery connector isconnected to a syringe barrel. The drug delivery connector can bepre-attached to the syringe by the device manufacturer. The syringebarrel may be pre-filled or may be filled by the user using a standardplunger rod and/or a hypodermic needle, or other means. A typicalsyringe barrel that may be utilized with one or more drug deliveryconnectors 100 is shown in FIG. 1 and includes a distal end 321 and anopen proximal end 329 and an end wall 322. A sidewall 324 may extendfrom the distal end 321 to the open proximal end 329 and may include aninterior surface 326 that defines a chamber 328 for holding liquids. Thedistal end 321 of the syringe barrel 300 may also include an open tip influid communication with the chamber 328.

A needle cannula (not shown) having a lumen (not shown) may be attachedto the open tip 314 of the syringe barrel for aspirating or filling thesyringe barrel 300 with medication. When attached to the open tip 314,the lumen (not shown) is in fluid communication with the open tip 314and the chamber 328 of the syringe barrel. The syringe barrel 300 mayinclude a luer lock attachment 310 or may also include or a luer slipfitting (not shown). The proximal connection portion 170 of embodimentsof the drug delivery connectors 100 described herein may include eithercorresponding fitting for secure engagement of syringe barrels havingboth types of luer fittings.

In one or more embodiments, permanent connection mechanisms may be builtin the drug delivery connector 100, so that, upon connection of drugdelivery connector 100 on to the syringe barrel 300 or other containerthe connection becomes permanent and the drug delivery connector andsyringe barrel 300 or other container are not detachable. Permanentconnection mechanisms may also be built in the actuator 200 so that,upon connection of actuator 200 to the catheter connector 210 or otherdrug delivery site, which may include a filter, the connection theconnection becomes permanent and the actuator 200 and the catheterconnector 210 are not detachable. The purpose of the permanentconnection is to prevent disconnections between the drug deliveryconnectors and containers or actuator and catheter connectors or otherdrug delivery sites, leaving only the joint between the drug deliveryconnector 100 and the actuator 200 being detachable. The permanentconnection can be realized by welding, which may include ultrasonicwelding, gluing, or through design, for example, by incorporating one ormore ratchet connector, special threads and other structures known inthe art.

Alternatively, instead of pre-assembling, the drug delivery connector100, actuator 200, syringe barrel 300 and/or catheter connector 210 maybe packed in the procedure trays or provided as standalone units. Insuch embodiments, the permanent connections can be built into one ormore of the drug delivery connector 100 and/or actuator 200 byincorporating ratchet connections, threaded connections or other knownstructures for connection known in the art.

In one or more embodiments the drug delivery connector 100 may beattached to the syringe barrel 300 when it is empty. Upon connection ofthe drug delivery connector 100 and the syringe barrel 300, the ballvalve 190 forms a seal with the distal wall 130 of the drug deliveryconnector 100 once medication enters the chamber 116 of the drugdelivery connector. In embodiments which incorporate a spring loadedball valve 190, the ball valve 190 forms a seal with the distal wall 130of the drug delivery connector 100 whether or not medication enters thechamber 116 of the drug delivery connector. In one or more embodiments,the presence of air within the syringe barrel 300 does not necessarilyclose the ball valve 190 and permits the user to expel any air fromwithin the syringe barrel 300. The formation of the seal between theball valve 190 and the distal wall 130 prevents the air and/ormedication contained within the syringe barrel 300 from exiting throughthe bore 132 of the distal wall 130. The drug delivery connector 100 mayremain unconnected or attached to an actuator 200, until the point atwhich the medication contained within the syringe barrel 300 is ready tobe delivered or administered to a patient.

To fill the syringe barrel 300, a hypodermic needle 400 may be attachedto the distal end of the drug delivery connector 100 that is attached toa syringe barrel 300. As shown in FIG. 17, the hypodermic needle 400 isattached to the distal connection portion 150 of the drug deliveryconnector 100 using a needle hub 410. In one or more embodiments, needlehub 410 may include an open distal end 411, an open proximal end 419 anda hub body 412 extending from the open distal end 411 to the openproximal end 419. The hypodermic needle 400 may be attached to the opendistal end 411 using methods known in the art, including adhesive andthe like. The hub body 412 includes an inside surface 414 defining a hubcavity 416.

In one or more embodiments, the hub body 412 includes an outside surface418. The outside surface 418 may include a projection 417 or ridgedisposed adjacent to the open proximal end 419 and extending outwardlyfrom the outside surface 418 for engagement with the distal connectionportion 150. In one or more embodiments, the projection 417 has a shapeand/or dimension to engage the treaded portion 162 disposed on theinside surface 158 of the coaxial wall 156 of the distal connectionportion 150.

In one or more embodiments, the outside surface 154 of the elongate tube152 is tapered or has a cross-sectional width that increases from thesidewall 112 of the housing to the open distal end 101 of the housing.In one or more alternative embodiments, outside surface 154 of theelongate tube 152 is contoured or is shaped to frictionally engage theinside surface 414 of the hub 440. According to a specific embodiment,the inside surface 414 of the hub body 412 is contoured or shaped tofrictionally engage the outside surface 154 of the elongate tube 152 ofthe distal connection portion 150.

After attachment of the hypodermic needle 400 to the distal connectionportion 150 of the drug delivery connector, the desired amount ofmedication can be aspirated or filled into the syringe barrel 300. Inthe embodiment shown in FIG. 17, the syringe barrel 300, drug deliveryconnector 100 and hypodermic needle 400 are positioned to drawmedication from a medication source, shown in FIG. 16 as a vial 420. Aplunger rod 320 is shown inserted into the syringe barrel 300 and aforce is applied to the plunger rod in the proximal direction drawingmedication into the syringe barrel 300.

As shown in FIG. 18, the force of the medication being drawn oraspirated into the syringe barrel 300 applies a force on the ball valve190 in the proximal direction, releasing the seal between the ball valve190 and the distal wall 130 of the drug delivery connector 100. Themedication enters the chamber 116 of the drug delivery connector 100 andpasses through the proximal connection portion 170 into the syringebarrel. After drawing the desired amount of medication, the hypodermicneedle may be removed. Once the hypodermic needle is removed, as shownin FIG. 19, the ball valve 190 closes and forms a fluid-tight seal withthe distal wall 130 of the drug delivery connector 100. Specifically,the medication within the syringe barrel 300 exerts a force on the ballvalve in the distal direction, forcing the ball valve against the distalwall 130, or more particularly, the perimeter 134 of the distal wall130. When a bolus is needed, the syringe barrel-drug deliver connectorassembly is connected to an actuator 200.

In one or more embodiments, when the drug delivery connector 100 and acontainer, for example the syringe barrel 300, are attached, the usermay remove air from the syringe barrel 300 by inverting the syringebarrel 300 and drug delivery connector 100 or position the assembledsyringe barrel 300 and drug delivery connector 100 so the medicationwithin the syringe barrel 300 moves, by gravity, in the proximaldirection relative to the drug delivery connector 100 and the air withinthe syringe barrel 300 moves, by gravity, in the distal directionrelative to the medication into the chamber 116 of the drug deliveryconnector 100. In this position, the ball valve 190 will float or dropdown toward the proximal wall 140 and the seal between the ball valve190 and the distal wall 130 is released. As the user applies a force tothe plunger rod 320 of the syringe in the distal direction, the airtrapped within the chamber 116 of the drug delivery connector 100 and/orsyringe barrel 300 is allowed to escape through the aperture 142 of theproximal wall 140 and the open distal end 151 of the distal connectionportion 150. Simultaneously, the medication contained within the syringebarrel 300 is forced into the chamber 116 of the drug delivery connector100 by the force exerted on the medication by the plunger rod 320. Themedication entering the chamber 116 exerts a force or pressure on theball valve 190 in the distal direction, causing the ball valve 190 tomove distally and reform the seal with the distal wall 130 and preventfluid communication through the bore 132 of distal wall 130. The sealedbore 132 prevents the user from directly injecting the medicationcontained within the syringe barrel 300 into any port without the use ofan actuator having a specific shape and/or dimensions to open the seal.

To open the ball valve 190 and administer the medication containedwithin the syringe barrel 300, the actuator 200 is attached to the opendistal end 101 of the drug delivery connector 100. The actuator 200includes a catheter connector 210. As shown in more detail in FIGS.20-21, suitable actuators 200 include an open distal end 211, a proximalend 219, and a longitudinally extending projection 212 extending in theproximal direction from the distal end 211 to the proximal end 219. Theproximal end 219 of the actuator 200 is unattached to any structure andmay be described as “cantilevered” or a projection 212 that is supportedon only one end. The proximal end 219 of the actuator 200 may bedescribed as a blunt tip or rounded tip. In one or more embodiments, theproximal end 219 has an outer diameter that is larger than the innerdiameter of standard luer slip connections utilized in most IVmedication delivery syringes to prevent accidental connection of IVmedication-containing syringes with the actuator 200 and to preventaccess to the anesthesia catheter.

In one or more embodiments, the projection 212 has a length that permitsthe proximal end 219 of the actuator 200 to extend into the chamber 116of the drug delivery connector 100, upon attachment of the actuator 200to the distal connection portion 150 of the drug delivery connector 100.The projection 212 includes one or more apertures or open paths 214extending along the length of the projection 212 to permit themedication within the syringe barrel 300 and chamber 116 of the drugdelivery connector 100 to flow from the drug delivery connector 100 to adelivery site that is attached to the distal end 211 of the actuator200. In one or more embodiments, the projection 212 is in the form oftwo perpendicularly intersecting beams that extend in the proximaldirection and define four openings. In one or more embodiments, theintersecting beams may include a solid end at the proximal end 219 ofthe actuator 200. In one or more embodiments, the solid end is in theform of a hemi-sphere (not shown). In a specific embodiment, theprojection 212 is in the form of a single, proximally extending beam(not shown) that defines two apertures or open paths 214. In a morespecific embodiment, the projection 212 includes a hollow member (notshown) that extends proximally and includes a conduit (not shown)extending from the open distal end 211 to the apertures or open paths214 at the proximal end 219 of the actuator 200.

In the embodiment shown in FIGS. 20-21, the actuator includes a femalefitting or a hub 220. In one or more embodiments, the hub 220 includesan open proximal end 229, an open distal end 221 and a wall 222extending from the open proximal end 229 to the open distal end 221 ofthe hub. The open distal end 211 of the projection 212 is attached tothe open distal end of the hub 220 and extends along the length of thehub 220 to the open proximal end 229. In one or more embodiments, thewall 222 includes having an outside surface 224 that includes a luerlock structure. In a specific embodiment, the luer lock structureincludes at least one radially outwardly extending portion that engagesthe threaded portion 162 disposed on the inside surface 158 of thecoaxial wall 156 of the distal connection portion 150 of the drugdelivery connector. In the embodiment shown in FIGS. 1-23, the radiallyoutwardly extending portion includes two radially outwardly extendingtabs 227, 228. In an even more specific embodiment, the radiallyoutwardly extending portion 226 includes a peripheral lip (not shown).In one or more embodiments, the inside surface 225 of the wall 222 mayhave a luer slip structure. In a specific embodiment utilizing a luerslip structure (not shown), the inside surface 225 of the wall maydefine a tapered cross-sectional width that increases from the opendistal end 221 to the open proximal end 229 and is shaped or contouredto frictionally engage a standard luer slip male fitting incorporated inalternative embodiments of a distal connection portion 150.

In the embodiment shown, the wall 222 of the hub 220 is formed in acoaxial relationship to the projection 212 of the actuator and defines acavity 216. The hub may be securely engaged to the distal end 211 of thedrug delivery connector 100 by inserting the actuator 200 into thepassageway 155 of the elongate tube 152 of the distal connection portion150 of the drug delivery connector. Where the hub 220 utilizes a luerlock structure, the drug delivery connector 100 and/or the hub 220 maybe rotated with respect to each other. In embodiments of the hub 220utilizing a luer slip structure (not shown), the drug delivery connector100 is inserted into the 216 cavity of the hub 220 until sufficientfrictional interference is formed between the drug delivery connector100 and the inside surface 225 of the hub 220.

In the embodiment shown in FIGS. 20-21, the projection 212 has an axiallength that permits the proximal end 219 of the actuator 200 to exert aforce on the ball valve 190 in the proximal direction and cause the ballvalve 190 move in the proximal direction and release the seal betweenthe ball valve 190 and distal wall 130, as shown in FIGS. 22-23. In oneor more embodiments, the force exerted on the ball valve 190 in theproximal direction is greater than the force exerted on the ball valve190 in the distal direction by the medication within the syringe barrel300 and/or chamber 116 of the drug delivery connector 100. In analternative embodiment of the drug delivery connector 100 whichincorporates structure to prevent proximal movement of the ball valve190, the force exerted on the ball valve 190 by the actuator 200 isgreater than the force exerted on the ball valve 190 by the structures.

The amount of force exerted on the ball valve 190 may be adjusted tocontrol or meter the flow rate of the medication through the projection212. In one or more embodiments, the projection 212 causes movement ofthe ball valve in the proximal direction prior to full attachment of thehub 220 and the distal connection portion 150. In a specific embodiment,the projection 212 causes proximal movement of the ball valve 190 whenthe hub 220 is fully attached to the distal connection portion 150.

In accordance with one or more embodiments, the length of the projection212 may be adjusted to control or meter the amount of force exerted onthe ball valve 190 to control or meter the flow rate of the medicationcontained within the syringe barrel 300 and/or chamber 116 of the drugdelivery connector 100. In a specific embodiment, the length of thedistal connection portion 150 and/or hub 220 may be adjusted to controlor meter the amount of force exerted on the ball valve 190 to control ormeter the flow rate of the medication contained within the syringebarrel 300 and/or chamber 116 of the drug delivery connector 100. Insuch embodiments, the user may control the flow rate by the amount anddirection of rotational force used to engaging the hub 220 and/or distalconnection portion 150. For example, if the flow rate is to beincreased, the user would rotate the hub 220 and/or distal connectionportion 150 so the hub 220 moves in the proximal direction relative tothe distal connection portion 150 and engages more of the threadedportion 162 or so the hub 220 and/or distal connection portion 150 aremore fully or completely engaged. This relative proximal movement orincreased level of engagement between the hub 220 and the distalconnection portion 150 causes the projection 212 to apply a greaterforce in the proximal direction to the ball valve 190 and widening thespace between the distal wall 130 and the ball valve 190. During thisadjustment, the force applied by the projection 212 on the ball valve190 would increase relative to the fluid pressure exerted on the ballvalve 190 in the distal direction from the flow of the medication out ofthe syringe barrel 300. If the flow rate is to be decreased, the userwould rotate the hub 220 and/or distal connection portion 150 to rotatethe hub 220 and/or distal connection portion 150 so the hub 220 moves inthe distal direction relative to the distal connection portion 150 andengages less of the threaded portion 162 of the distal connectionportion 150 so the hub 220 and/or distal connection portion 150 are lessfully or completely engaged. This relative distal movement or decreasedlevel of engagement causes the projection 212 to apply a smaller forcein the proximal direction to the ball valve 190, thereby narrowing thespace between the distal wall 130 and the ball valve 190. During thisadjustment, the fluid pressure exerted on the ball valve 190 from thedistal direction by the flow of the medication of the syringe barrel 300would increase relative to the force exerted on the ball valve 190 inthe distal direction by the projection 212.

In one or more embodiments, the actuator 200 may include a shield (notshown) extending from the distal end 221 of the hub 220 toward theproximal end 219 of the actuator 200. The shield (not shown) may be usedto guide the connection between the actuator 200 and the drug deliveryconnector 100. In one or more embodiments, the shield (not shown) mayserve as a guide to facilitate connection of the drug delivery connectorand the actuator. In addition, the shield (not shown) may protect theactuator from lateral pressure, which may cause the actuator to break,and/or prevent contamination of the actuator.

In one or more embodiments, the shield (not shown) may be provided inthe form of a peripheral wall surrounding the hub 220. The peripheralwall (not shown) may be formed to permit space between the hub andperipheral wall to accommodate any external structures of the syringebarrel 300 and syringe tip. In one or more embodiments, the peripheralwall (not shown) may have a constant cross-sectional width. In aspecific embodiment, the peripheral wall (not shown) may have a taperedcross-sectional width increasing from the distal end 221 of the hub 220to the proximal end 229 of the hub 220. The peripheral wall (not shown)may have an expanded cross-sectional width proximally adjacent to thetapered cross-sectional width. The length of the peripheral wall (notshown) may extend from the distal end 221 of the hub 220 beyond theproximal end 229 of the hub. In one or more embodiments, the length ofthe peripheral wall (not shown) terminates at the proximal end 219 ofthe actuator 200. In an alternative embodiment, the length of theperipheral wall (not shown) terminates at the proximal end 229 of thehub 220. In one or more embodiments, the peripheral wall (not shown) maybe composed of a clear material so the user may ensure completeconnection between the hub 220 and the drug delivery connector 100. Theperipheral wall (not shown) may be composed of an extruded or moldedplastic material.

In one or more embodiments, a catheter connector 210 is attached to theactuator 200 extends distally from the distal end 211 of the hub 220 andactuator 200. The one or more apertures or open paths 214 of theprojection 212 and the open distal end 221 of the hub 220 are in fluidcommunication with the catheter connector 210. The catheter connector210 may include a luer lock fitting 230 or a luer slip fitting (notshown) for attachment of the actuator 200 to devices such as catheters,a needle, for example, a spinal needle, an epidural needle, or ahypodermic needle and/or filters, for example, epidural filters.

In one or more embodiments, luer lock fitting 230 of the catheterconnector 210 may include an open distal end 231 an open proximal end influid communication with the open distal end 221 of the hub 220 and thedistal end 211 of the actuator 200. As shown in FIGS. 20-23, thecatheter connector 210 may include a tubular body 232 extending from theopen distal end 231 to the open proximal end 239. A luer wall 234 maysurround the tubular body 232 and form a groove 236 between the tubularbody 232 and the luer wall 234. The luer wall 234 may also include aninside surface 237 including a plurality of threads 238 for engaging acatheter, filter or other delivery site.

As shown in FIGS. 21-22, during assembly of the actuator 200 to the drugdelivery connector 100 and syringe barrel 300, the proximal end 219 ofthe actuator 200 is inserted into the passageway 155 of the elongatetube 152 of the distal connection portion 150 of the drug deliveryconnector. The projection 212 is extended through the bore 132 of thedistal wall 130 and enters into the chamber 116. Continuous applicationof a force on the actuator 200 in the proximal direction, whether or notthe force includes rotational forces from the hub 220 being threadedinto the threaded portion 162 of the distal connection portion 150,exerts a proximally directed force on the ball valve 190 to release theseal formed between the ball valve 190 and the perimeter 134 of thedistal wall 130 at the bore.

In embodiments which utilize a coil spring 192 with the ball valve 190,the actuator 200 exerts a force on the ball valve 190 in the proximaldirection that compresses the coil spring 192 and moves the ball valve190 in a proximal direction away from the distal wall 130. The actuator200 applies a greater force in the proximal direction on the ball valve190 to overcome the force exerted on the ball valve 190 by the coilspring 192. In embodiments which utilize a retaining ring 127 on theinterior surface 114 of the chamber 116 of the drug delivery connector,the actuator 200 applies a greater force in the proximal direction onthe ball valve 190 to overcome the distally directed force exerted onthe ball valve 190 by the retaining ring 127. Once the seal between theball valve 190 and the distal wall 130 is released, fluid communicationbetween the syringe barrel 300, the chamber 116 of the drug deliveryconnector and the actuator 200 is established and medication can beadministered from the syringe barrel 300 and drug delivery connector 100to the least one aperture or open path 214 of the projection 212 of theactuator 200 to the delivery port.

When the drug delivery connector 100 is coupled with the syringe barrel300 and actuator 200, the pressurized medication in the syringe barrel300 and drug delivery connector 100 passes around the ball valve 190through the bore 132 and distal connection portion 150 of the drugdelivery connector. In embodiments which utilize a plurality of ribs122, one longitudinal protrusion 120 and/or a plurality of longitudinalprotrusions 121 on the interior surface 114 of the chamber 116, flow ofthe medication is facilitated by the flow paths created by ribs 122,longitudinal protrusion 120 and/or plurality of longitudinal protrusions121, which permit a larger area around the ball valve 190 through whichthe medication can flow.

The position of the ball valve 190 utilizes the natural flow rate andpressure of the medication contained within the syringe barrel 300 toseal the bore 132 of the drug delivery connector 100. In other devicesknown in the art, the flow rate and direction of the medication isutilized, at least partially, to open such valves. In embodiments of thepresent invention, the actuator 200 overcomes the flow rate anddirection of the pressurized medication contained within the syringebarrel 300 to release the seal and deliver the medication to anappropriate delivery site. The embodiments described herein, provide anadditional safety mechanism by providing a structure that maintains theseal between the chamber 116 of the drug delivery connector thatinaccessible until the syringe and drug delivery connector are correctlyconnected to the appropriate delivery site via the actuator. Inaddition, the embodiments described herein forces the user to counteractnatural forces and enhance the steps required for connection of thesyringe barrel to a delivery site, such as a catheter. Moreover, thisconfiguration reduces the possibility of leakage or accidental expulsionof the medication contained in the syringe barrel, before connection toan appropriate delivery site. In addition, the position of the valve inthe drug delivery connector and/or the shape of the actuator preventmisconnection or access to delivery sites, such as anesthesia catheter,using IV medication syringes or other syringes that contain other typesof medication.

A second aspect of the present invention pertains to a method ofadministering epidural anesthesia to a catheter connector or otherdelivery site. In one or more embodiments, the method includes attachinga tip of an empty syringe barrel to an open proximal end of a drugdelivery connector as described herein that includes a ball valve forsealing the open distal end of the drug delivery connector. The methodfurther includes attaching a hypodermic needle having a cannula and anopening to the distal end of the drug delivery connector so the openingis in fluid communication with the syringe barrel. In one or moreembodiments, the method includes, aspirating an amount of an epiduralanesthesia into the syringe barrel through the hypodermic needle anddrug delivery connector. The fluid flow of the epidural anesthesia fromthe hypodermic needle releases the seal between the ball valve and theopen proximal end. In one or more embodiments, after a desired amount ofepidural anesthesia is aspirated, the method further includes removingthe hypodermic needle and attaching the distal end of the drug deliveryconnector to a catheter connector or other delivery site and expellingthe epidural anesthesia from the syringe barrel into the catheterconnector or other delivery site. After removal of the hypodermic needleand prior to connection of the drug delivery connector to the catheterconnector or other delivery site, the ball valve fluid flow from thesyringe barrel exerts a force on the ball valve in the distal directionto cause the ball valve to form a seal with the distal end of to preventfluid communication between the open distal end and the syringe barrelprior to connection with the catheter connector or other delivery site.In one or more embodiments, the method includes opening the seal formedbetween the ball valve and the open proximal end. In one or moreembodiments, opening the seal includes applying a force on the ballvalve in the distal direction. In one or more embodiments, the force isapplied to the ball valve in the distal direction by providing anactuator with a free proximal end extending proximally from the actuatorand inserting the actuator into the open distal end of the drug deliveryconnector and attaching the open distal end of the drug deliveryconnector to the actuator.

In an alternative embodiment, the method of administering epiduralanesthesia includes filling a syringe barrel having a tip with apre-determined amount of epidural anesthesia and attaching the tip ofthe syringe barrel to an open proximal end of a drug delivery connector,as described herein, including an open distal end and a ball valve forsealing the open distal end. In a specific embodiment, the method mayinclude removing air from within the syringe barrel and drug deliveryconnector after attachment of the tip to the open proximal end of thedrug delivery connector. According to one or more embodiments, themethod includes filling the drug delivery connector with the epiduralanesthesia to close the ball valve and seal the open distal end. In oneor more embodiments, the method includes attaching an actuator in fluidcommunication to the open distal end of the drug delivery connector. Ina specific embodiment, the method includes opening the seal by applyinga force in the proximal direction to the actuator to exert a proximallydirected force on the ball valve to open the ball valve.

Reference throughout this specification to “one embodiment,” “certainembodiments,” “one or more embodiments” or “an embodiment” means that aparticular feature, structure, material, or characteristic described inconnection with the embodiment is included in at least one embodiment ofthe invention. Thus, the appearances of the phrases such as “in one ormore embodiments,” “in certain embodiments,” “in one embodiment” or “inan embodiment” in various places throughout this specification are notnecessarily referring to the same embodiment of the invention.Furthermore, the particular features, structures, materials, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It will be apparent to those skilled in the art thatvarious modifications and variations can be made to the method andapparatus of the present invention without departing from the spirit andscope of the invention. Thus, it is intended that the present inventioninclude modifications and variations that are within the scope of theappended claims and their equivalents.

What is claimed is:
 1. A drug delivery connector comprising: a housingincluding an open distal end, an open proximal end and a chamber withinthe housing in fluid communication with the open distal end and the openproximal end, the housing including a distal connection portion and aproximal connection portion for attaching the housing to a container; aball valve enclosed within the chamber so that the ball valve floatsbetween the open distal end and the open proximal end in the chamber,wherein the ball valve is moveable in a distal direction to form areleasable seal with the open distal end to prevent fluid flow from theopen proximal end to the open distal end upon application of force inthe distal direction on the ball valve applied by fluid upon attachmentof a container containing the fluid to the proximal connection portion,the ball valve movable in a proximal direction to release the releasableseal to permit fluid flow from the open proximal end to the open distalend; and an actuator for attachment to the open distal end of thehousing, the actuator comprising an open distal end and a projectionextending in the proximal direction and including at least one aperturein fluid communication with the open distal end of the actuator and theopen distal end of the housing.
 2. The drug delivery connector of claim1, wherein the housing comprises a proximal wall disposed adjacent tothe open proximal end, the proximal wall including at least one apertureallowing constant fluid communication between the open proximal end andthe chamber.
 3. The drug delivery connector of claim 1, wherein thehousing comprises a distal wall disposed adjacent to the open distalend, the distal wall including a bore having a perimeter, the perimeterconfigured to contact the ball valve to form a releasable seal betweenthe ball valve and the distal wall.
 4. The drug delivery connector ofclaim 1, wherein the housing comprises a structure that forms one ormore fluid flow paths around the ball valve selected from one or more ofa longitudinal protrusion, a rib, an expanding sidewall and combinationsthereof.
 5. The drug delivery connector of claim 1, wherein the distalconnection portion comprises a luer lock fitting.
 6. The drug deliveryconnector of claim 1, wherein the proximal connection portion comprisesa lure lock fitting.
 7. The drug-delivery connector of claim 1, whereinupon attachment of the actuator to the open distal end of the housing,the projection applies a force on the ball valve in the proximaldirection to move the ball valve in the proximal direction.
 8. The drugdelivery connector of claim 1, wherein the chamber of the housingcomprises a retaining ring that inhibits movement of the ball valve inthe proximal direction.
 9. The drug delivery connector of claim 8,wherein the ball valve is movable in the proximal direction uponapplication of force in the proximal direction on the ball valve by theactuator, the force of the actuator being sufficient to overcome adistally directed force exerted on the ball valve by the retaining ring.10. A method of delivering liquid medication to a catheter connectorcomprising: attaching the actuator to the catheter connector of claim 1;attaching a tip of a syringe barrel to the open proximal end of a drugdelivery connector; filling the syringe barrel with a pre-determinedamount of liquid medication; filling the chamber of the drug deliveryconnector with the liquid medication to form a seal between the valveand the open distal end; and releasing the seal between the valve andthe open distal end by attaching the open distal end to the actuator.11. The method of claim 10, wherein releasing the seal comprises causingthe projection of the actuator to apply a force in a proximal directionto the valve.
 12. The method of claim 10, wherein releasing the sealpermits the liquid medication to flow from the chamber to the open path.